The medical device industry produces a wide variety of electronic and mechanical devices for treating patient medical conditions. Depending upon the medical condition, medical devices can be surgically implanted or connected externally to the patient receiving treatment. Clinicians use medical devices alone, or in combination with other medical devices, drug therapies, and surgery to treat patient medical conditions. For some medical conditions, medical devices provide the best, and sometimes the only, therapy to restore an individual to a more healthful condition and a fuller life.
Implantable medical devices are commonly used today to treat patients suffering from various ailments. Implantable medical devices can be used to treat any number of conditions such as pain, incontinence, movement disorders such as epilepsy and Parkinson's disease, and sleep apnea. Additionally, use of implantable medical devices appears promising to treat a variety of physiological, psychological, and emotional conditions.
One type of implantable medical device is an Implantable Neuro Stimulator (INS). The INS is implanted at a predetermined location in the patient's body. The INS generates and delivers mild electrical impulses to neurostimulation areas in the body using an electrical lead. The INS electrical stimulation signals at neurostimulation sites or areas influence desired neural tissue, tissue areas, nervous system and organs to treat the ailment of concern. The stimulation sites can also include the spinal cord, brain, body muscles, peripheral nerves or any other site selected by a physician. For example, in the case of pain, electrical impulses may be directed to cover the specific sites where the patient is feeling pain. Neurostimulation can give patients effective pain relief and can reduce or eliminate the need for repeat surgeries and the need for pain medications.
In the case to an INS, the system generally includes an implantable neuro stimulator (INS) (also known as an implantable pulse generator (IPG)), an external physician or clinician programmer, a patient programmer and at least one electrical lead. An INS is typically implanted near the abdomen of the patient, or other stimulation area as required. The lead is a small medical wire with special insulation and contains a set of electrodes small electrical contacts) through which electrical stimulation is delivered. The INS can be powered by an internal source such as a rechargeable or non-rechargeable battery or by an external source such as a radio frequency transmitter. The INS contains electronics to generate and send precise. electrical pulses to the stimulation area to provide the desired treatment therapy. The clinician programmer is an external device that allows the physician or clinician to create and store preset stimulation therapy to be delivered by the INS. The clinician programmer communicates with the INS using radio waves, for example via telemetry. The patient programmer is an external hand-held device that allows the patient to optimize the stimulation therapy delivered by the INS. The patient programmer also communicates with the INS using radio waves, such as telemetry.
Another type of implantable medical device is an implantable drug infusion pump. The drug infusion pump is implanted at a predetermined location in the patient's body. Typically, the implantable drug infusion pump outlet is connected to the proximal end of an infusion catheter. The catheter is a flexible tube with a lumen typically running the length of the catheter. The distal end of the catheter is positioned to infuse a drug or drug combination to target sites in a patient's body. Target sites in a patient's body include but are not limited to an internal cavity, a blood vessel, any organ, other tissue or fluid in the body The drug or other therapeutic substance flows from the pump through the lumen in the catheter at a programmed rate. The drug or drug combination is intended to have a therapeutic effect such as pharmaceutical compositions, genetic materials, biologics, and other substances. Pharmaceutical compositions are chemical formulations intended to have a therapeutic effect such as intrathecal antispasmodics, pain medications, chemotherapeutic agents, and the like.
In the case of the implantable drug infusion pump, the system generally includes an implantable drug infusion pump, an external physician or clinician programmer, a patient programmer, and an infusion catheter. The implantable drug infusion pump contains a power source and electronics that allow the correct flow of therapeutic to be delivered to the treatment area. The physician or clinician programmer is used to create and store preset infusion therapies to be delivered by the implantable drug infusion pump. The clinician programmer communicates with the implantable drug infusion pump using radio waves, for example via telemetry. The patient programmer is an external hand-held device that allows the patient to optimize the stimulation therapy delivered by the implantable drug infusion pump. The patient programmer also communicates with the implantable drug infusion pump using telemetry.
A third type of implantable medical device is a combination medical device. Both the INS and the implantable drug infusion pump may also be used in combination to provide a more effective therapy. In some applications, the efficacy of treatment may be enhanced if tissue-requiring treatment is stimulated while drugs are being administered. Additionally, one system could be used as a base treatment system with the other providing additional treatment if the base system cannot provide an adequate response. In such a system, the combination devices could be separately housed devices or devices that share a common housing. The system may include both an INS and an implantable drug infusion pump along with a common infusion catheter that contains both a lumen and electrodes to provide the treatment.
In the above devices or combination devices, a clinician typically creates and stores preset patient therapy programs that are executed by the devices to deliver therapy to the patient. The preset patient therapy programs include specific therapy parameters that are set and created by clinicians based on industry or clinician preferences, patient feedback, a patient's test results, or a combination of all of the above. The patient therapy programs are then downloaded into the devices memory using the clinician programmer. The patient therapy programs then reside in both clinician programmer memory and the devices memory. The stored preset patient therapy programs, which include specific therapy parameters, will allow the devices to generate the appropriate electrical stimulation signals or drug infusion flows for the patient's specific needs. The stored patient therapy programs may contain parameters, which include for example, electrode settings, signal intensity or strength (amplitude), signal duration (pulse width), signal timing and cycling (pulse frequency or rate), drug infusion volume, start time, and stop time.
At present, patients do not have the ability to select and assemble the preset therapy programs, which were created by the clinician, or to create his/her own personalized therapy programs. A patient can typically access the stored preset clinician therapy programs but cannot create personalized therapy programs himself/herself. A patient must use and live with the preset therapy programs that have been created by the clinician. Moreover, the targeted treatment areas by the implantable medical devices are usually situated to alleviate or address pain or discomfort due to one body position or activity, e.g., sitting compared to walking, jogging or running. As a result, the combination of specifically situated stimulation and/or infusion areas and unchangeable clinician created preset therapy programs can lead to discomfort or reduced therapy when a patient engages in activities that were not accounted for or foreseen by the clinician. The inability to modify the stored therapy programs can thus limit the activities that a patient may wish to engage in.
For the foregoing reasons there is a need for a method and system that will allow patients to access stored preset clinician therapy programs so that the patient can create new personalized therapy programs that will enable the patient to participate in a variety of activities without undue discomfort or the need to visit a clinician for additional preset therapy programs.
It is an objective of the present invention to provide a method and system to give patients the ability to assemble, label and store their own personalized therapy programs, on demand, from among the preset clinician therapy programs that are resident in device's memory.
It is an objective of the present invention to provide a method and system to give patients more control to create personalized therapy programs and settings to fit their unique lifestyles thereby increasing patient satisfaction.